Role of mesenchymal stromal cells derivatives in diabetic foot ulcers: a controlled randomized phase 1/2 clinical trial

Arango-Rodríguez, Martha L.; Solarte-David, Víctor Alfonso; Becerra-Bayona, Silvia; Callegari, Eduardo; Paez, María D.; Sossa, Claudia; Vera, Miguel Enrique Ochoa; Mateus, Ligia C; Gómez, Sergio Eduardo Serrano; Ardila-Roa, Andrea K.; Viviescas, Lady T. Giratá

doi:10.1016/j.jcyt.2022.04.002

Cited by 10 publications

(10 citation statements)

References 72 publications

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“…Although outcome blind there was a high loss to follow‐up with a per‐protocol analysis only presented. A three way study in 28 participants 210 of allogeneic bone marrow mesenchymal stromal cells (allohBM MSC) investigated allogeneic bone marrow mesenchymal stromal cell derivatives (cultured allohBM MSCs) versus controls. Hazard ratios for healing at 7 weeks were presented, but the actual numbers of ulcers healed were not given.…”

Section: Resultsmentioning

confidence: 99%

“…We found 10 papers describing RCTs of other cell therapies for the promotion of healing of diabetes-related foot ulcers, including adipocytes, [201][202][203][204][205] Fibroblasts, 206 keratinocytes, 207,208 bone marrow derived stem cells, 209 allogeneic bone marrow mesenchymal stromal cells (allohBM MSC) and cultured allogeneic bone marrow mesenchymal stromal cell derivatives (cultured allohBM MSCs). 210 Those describing our outcomes of critical interest are described below.…”

Section: Other Cell Therapiesmentioning

confidence: 99%

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Effectiveness of interventions to enhance healing of chronic foot ulcers in diabetes: A systematic review

Chen,

Vilorio,

Dhatariya

et al. 2024

Diabetes Metabolism Res

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BackgroundIt is critical that interventions used to enhance the healing of chronic foot ulcers in diabetes are backed by high‐quality evidence and cost‐effectiveness. In previous years, the systematic review accompanying guidelines published by the International Working Group of the Diabetic Foot performed 4‐yearly updates of previous searches, including trials of prospective, cross‐sectional and case‐control design.AimsDue to a need to re‐evaluate older studies against newer standards of reporting and assessment of risk of bias, we performed a whole new search from conception, but limiting studies to randomised control trials only.Materials and MethodsFor this systematic review, we searched PubMed, Scopus and Web of Science databases for published studies on randomised control trials of interventions to enhance healing of diabetes‐related foot ulcers. We only included trials comparing interventions to standard of care. Two independent reviewers selected articles for inclusion and assessed relevant outcomes as well as methodological quality.ResultsThe literature search identified 22,250 articles, of which 262 were selected for full text review across 10 categories of interventions. Overall, the certainty of evidence for a majority of wound healing interventions was low or very low, with moderate evidence existing for two interventions (sucrose‐octasulfate and leucocyte, platelet and fibrin patch) and low quality evidence for a further four (hyperbaric oxygen, topical oxygen, placental derived products and negative pressure wound therapy). The majority of interventions had insufficient evidence.ConclusionOverall, the evidence to support any other intervention to enhance wound healing is lacking and further high‐quality randomised control trials are encouraged.

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Section: Resultsmentioning

confidence: 99%

Section: Other Cell Therapiesmentioning

confidence: 99%

Effectiveness of interventions to enhance healing of chronic foot ulcers in diabetes: A systematic review

Chen,

Vilorio,

Dhatariya

et al. 2024

Diabetes Metabolism Res

View full text Add to dashboard Cite

show abstract

“…This group of interventions included other cell therapies for the promotion of healing of diabetes-related foot ulcers, including adipocytes, [189][190][191][192][193] fibroblasts, 194 keratinocytes, 195,196 bone marrowderived stem cells, 197 allogeneic bone marrow mesenchymal stromal cells (allohBM MSC), and cultured allogeneic bone marrow mesenchymal stromal cells derivatives (cultured allohBM MSCs). 198 Recommendation 21: We suggest not using other cell therapy as an adjunct therapy to standard of care for wound healing in people with diabetes-related foot ulcers (Conditional; Low). Rationale: In total, 10 studies were identified.…”

Section: Other Cell Therapiesmentioning

confidence: 99%

“…These included studies investigating autologous adipocytes, [189][190][191][192][193] fibroblasts, 194 keratinocytes, 195,196 bone marrow-derived stem cells, 197 allogeneic bone marrow mesenchymal stromal cells (allohBM MSC), and allogeneic bone marrow mesenchymal stromal cells derivatives (cultured allohBM MSCs). 198 Of the adipocyte or adipocyte stem cell studies which reported complete healing, only two were outcome-blinded. There was heterogeneity of outcomes with some studies showing no improvement in healing, and those reporting positive benefit being at high risk of bias.…”

Section: Other Cell Therapiesmentioning

confidence: 99%

Guidelines on interventions to enhance healing of foot ulcers in people with diabetes (IWGDF 2023 update)

Chen,

Vilorio,

Dhatariya

et al. 2023

Diabetes Metabolism Res

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AimsPrinciples of wound management, including debridement, wound bed preparation, and newer technologies involving alternation of wound physiology to facilitate healing, are of utmost importance when attempting to heal a chronic diabetes‐related foot ulcer. However, the rising incidence and costs of diabetes‐related foot ulcer management necessitate that interventions to enhance wound healing of chronic diabetes‐related foot ulcers are supported by high‐quality evidence of efficacy and cost effectiveness when used in conjunction with established aspects of gold‐standard multidisciplinary care. This is the 2023 International Working Group on the Diabetic Foot (IWGDF) evidence‐based guideline on wound healing interventions to promote healing of foot ulcers in persons with diabetes. It serves as an update of the 2019 IWGDF guideline.Materials and MethodsWe followed the GRADE approach by devising clinical questions and important outcomes in the Patient‐Intervention‐Control‐Outcome (PICO) format, undertaking a systematic review, developing summary of judgements tables, and writing recommendations and rationale for each question. Each recommendation is based on the evidence found in the systematic review and, using the GRADE summary of judgement items, including desirable and undesirable effects, certainty of evidence, patient values, resources required, cost effectiveness, equity, feasibility, and acceptability, we formulated recommendations that were agreed by the authors and reviewed by independent experts and stakeholders.ResultsFrom the results of the systematic review and evidence‐to‐decision making process, we were able to make 29 separate recommendations. We made a number of conditional supportive recommendations for the use of interventions to improve healing of foot ulcers in people with diabetes. These include the use of sucrose octasulfate dressings, the use of negative pressure wound therapies for post‐operative wounds, the use of placental‐derived products, the use of the autologous leucocyte/platelet/fibrin patch, the use of topical oxygen therapy, and the use of hyperbaric oxygen. Although in all cases it was stressed that these should be used where best standard of care was not able to heal the wound alone and where resources were available for the interventions.ConclusionsThese wound healing recommendations should support improved outcomes for people with diabetes and ulcers of the foot, and we hope that widescale implementation will follow. However, although the certainty of much of the evidence on which to base the recommendations is improving, it remains poor overall. We encourage not more, but better quality trials including those with a health economic analysis, into this area.

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“…As a result, no adverse events were reported. Compared with patients receiving conventional treatment, the wound closure rate of DFU patients treated with allogeneic BM-MSCs derivatives or allogeneic BM-MSCs was higher ( 255 ). Uzun et al.…”

Section: Mscs and Stem Cellsmentioning

confidence: 99%

Function and mechanism of mesenchymal stem cells in the healing of diabetic foot wounds

Liu

et al. 2023

Front. Endocrinol.

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Diabetes has become a global public health problem. Diabetic foot is one of the most severe complications of diabetes, which often places a heavy economic burden on patients and seriously affects their quality of life. The current conventional treatment for the diabetic foot can only relieve the symptoms or delay the progression of the disease but cannot repair damaged blood vessels and nerves. An increasing number of studies have shown that mesenchymal stem cells (MSCs) can promote angiogenesis and re-epithelialization, participate in immune regulation, reduce inflammation, and finally repair diabetic foot ulcer (DFU), rendering it an effective means of treating diabetic foot disease. Currently, stem cells used in the treatment of diabetic foot are divided into two categories: autologous and allogeneic. They are mainly derived from the bone marrow, umbilical cord, adipose tissue, and placenta. MSCs from different sources have similar characteristics and subtle differences. Mastering their features to better select and use MSCs is the premise of improving the therapeutic effect of DFU. This article reviews the types and characteristics of MSCs and their molecular mechanisms and functions in treating DFU to provide innovative ideas for using MSCs to treat diabetic foot and promote wound healing.

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Role of mesenchymal stromal cells derivatives in diabetic foot ulcers: a controlled randomized phase 1/2 clinical trial

Cited by 10 publications

References 72 publications

Effectiveness of interventions to enhance healing of chronic foot ulcers in diabetes: A systematic review

Effectiveness of interventions to enhance healing of chronic foot ulcers in diabetes: A systematic review

Guidelines on interventions to enhance healing of foot ulcers in people with diabetes (IWGDF 2023 update)

Function and mechanism of mesenchymal stem cells in the healing of diabetic foot wounds

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